297 F. Supp. 3d 222
D.D.C.2018Background
- Amphastar (and subsidiary IMS) develop and manufacture generic enoxaparin; Momenta owns the '886 patent (testing method) and had a collaborative, profit‑sharing license agreement with Sandoz, the first FDA‑approved generic seller.
- Momenta representatives (including inventor Dr. Shriver) participated in USP standard‑setting for enoxaparin while failing to disclose conflicts tied to the pending '886 patent and the Collaboration Agreement.
- USP adopted the so‑called 207 Method (after Aventis abandoned a patent application), and Amphastar alleges the FDA conditioned approval on using the USP method.
- Momenta later sued Amphastar for patent infringement two days after Amphastar obtained FDA approval. Amphastar alleges this and the prior conduct excluded it from the market and inflated prices.
- Amphastar brought Sherman Act (Sections 1 and 2), California antitrust and unfair competition claims; Momenta moved to dismiss. This Court denied dismissal and rejected several of Momenta’s arguments (including compulsory‑counterclaim and failure‑to‑plead causation/conspiracy) at the 12(b)(6) stage.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Causation / Antitrust injury | Momenta's deception of USP caused USP adoption of Method 207, FDA conditioned approval on that method, and that materially caused Amphastar's injury | Amphastar adopted Method 207 in its ANDA years earlier; no causal link between USP proceedings and Amphastar's FDA approval/injury | Court: Amphastar plausibly alleged material causation — the injury can be traced to defendants' conduct before USP and the FDA's reliance; question for factfinder |
| Monopolization / Restraint through standard setting | Momenta deceived USP to get a standard that reads on the '886 patent, creating exclusionary power and a mandatory test | 207 Method was not mandatory; alternatives existed; defendants opposed adoption, so not deceptive | Court: Allegations suffice to plead §2 and §1 claims; whether 207 was effectively mandatory and alternatives feasible are factual issues inappropriate at dismissal |
| Compulsory counterclaim / claim preclusion | Antitrust claims arise from Momenta's assertion of the patent but are distinct causes of action; permitted after Mercoid/Fowler | Antitrust claims were compulsory and should have been raised in earlier patent suit | Court: Mercoid/Fowler control — antitrust treble‑damage claims (patent misuse of a valid patent) are permissive; not barred as compulsory counterclaims |
| Conspiracy (Section 1) | Collaboration Agreement and payment terms created financial incentives and concerted action with Sandoz to exclude rivals; Sandoz participated in USP meetings | Allegation of Sandoz joining a conspiracy is conclusory; no specific facts tying Sandoz to deceptive intent | Court: Complaint sufficiently alleges a conscious agreement and financial motive; §1 conspiracy claim survives dismissal |
Key Cases Cited
- Ashcroft v. Iqbal, 556 U.S. 662 (pleading standard: factual plausibility)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (antitrust pleading requires plausible conspiracy allegations)
- Broadcom Corp. v. Qualcomm, Inc., 501 F.3d 297 (deception before standards body can give rise to antitrust liability)
- Mercoid Corp. v. Mid-Continent Inv. Co., 320 U.S. 661 (antitrust treble‑damage claims as permissive, not compulsory, counterclaims to patent suits)
- Fowler v. Sponge Prods. Corp., 246 F.2d 223 (First Circuit applying Mercoid — antitrust counterclaims permissive)
- Sterling Merch., Inc. v. Nestle, S.A., 656 F.3d 112 (elements of monopolization claim under §2)
- Evergreen Partnering Grp., Inc. v. Pactiv Corp., 720 F.3d 33 (§1 requires conscious commitment to common scheme)
- Monsanto Co. v. Spray-Rite Serv. Corp., 465 U.S. 752 (same: concerted action / conscious commitment)